Objective:Concurrent chemoradiotherapy is considered to be the standard for patients with locally advanced(T3T4/N2N3) head and neck squamous cell carcinoma.Whether induction chemotherapy before concurrent chemoradiation could further improve survival or not is still controversial internationally.This randomized control trial will analyze the results of induction chemotherapy combined with concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma(LAHNSCC).Methods: 120 cases with LAHNSCC treated in our hospital from January 2005 to June 2007 were randomized to Treatment Group(NAC+CCR) and Control Group(CCR).60 cases in the Treatment Group received induction chemotherapy followed by concurrent chemoradiotherapy

while 60 cases in the Control Group accepted concurret chemoradiotherapy alone.All the patients were inoperable.The majority had T4 or N3(92.5% and 70.0%

respectively).NAC+CCR was given two cycles neo-chemotherapy of paclitaxel

135~150 mg/m2

and cisplatin

75~100 mg/m2 on day 1

every 3 weeks followed by chemoradiotherapy with the same regimen on day 1

day 22 and 43 during radiotherapy.CCR received chemoradiotherapy of paclitaxel

135~150 mg/m2

and cisplatin

75~100 mg/m2 on day 1

day 22 and 43 during radiotherapy.The radiation dose and radiation time of both groups were comparable.The median radiation dose of primary tumor was 70 Gy(66~74 Gy).Radiation dose of neck positive lymph node drainage region was 66~70 Gy.The median radiation time was 51 days(46~59 days).The survival rates were analyzed and compared by Kaplan-Meier and Log-rank.Results:(1)Group NAC+CCR tends to improve the overall survival(OS) and progression free survival(PFS) but no reach significant difference

compared with group CCR.the 1

3 and 5-year OS of group NAC+CCR and CCR was 86.94% vs 73.16%;36.82% vs 33.59%;25.09% vs 20.11%

respectively

χ2=1.288

P=0.256

while the 1

3 and 5-year PFS was 70.18% vs 61.84%;31.84% vs 28.71%;21.66% vs 16.71%

respectively

χ2=1.972

P=0.160.The median OS time of group NAC+CCR and CCR was 26.97 and 23.66 months respectively.(2)Complete response rates at 12 weeks from the end of therapy were 65.0% with group NAC+CCR and 26.7% with group CCR(χ2=17.76

P=0.00).(3)There was no significant difference between group NAC+CCR and CCR in both the incidences of grade 3 or 4 acute adverse reactions and long-term complications.(4)The distant metastasis rate of group NAC+CCR was obviously lower than that of group CCR

15.0% vs 33.3%(χ2=5.50

P=0.02).Conclusion:Compared with group CCR

NAC+CCR could significantly improve the recent complete response rates and reduce metastasis incidence

and it also had a trend to improve OS and PFS

having no increased the incidence of recent and long-term adverse reaction

therefore

it may become one of the standard treatment for LAHNSCC.